Category Archives: Advocacy

IOM On The Case

Posted on August 29, 2013 by Jennie Spotila

No announcement and no fanfare, but it became public this week that the Office of the Assistant Secretary intends to award a sole source contract to the Institute of Medicine to create a consensus clinical definition for ME/CFS. Here’s the … Continue reading →

Posted in Advocacy, Commentary | Tagged , , , , | 5 Comments

Drug and FDA News, August 2013

Posted on August 23, 2013 by Jennie Spotila

Next week, I will be attending the FDA’s Patient Representative Workshop for new patient reps. The meeting is 1.5 days of orientation and discussion, and I am eager to meet my fellow patient representatives. I will report back on the … Continue reading →

Posted in Advocacy | Tagged , , , | Comments Off on Drug and FDA News, August 2013

The Full Ninety

Posted on August 22, 2013 by Jennie Spotila

Ninety-one days have passed since the last CFS Advisory Committee meeting. As of the date and time of this post, none of the materials related to the meeting have been posted on the CFSAC website. Federal law requires that the … Continue reading →

Posted in Advocacy | Tagged , , , | 8 Comments

CFSAC Interviews

Posted on August 20, 2013 by Jennie Spotila

Gabby Klein has written an article for Phoenix Rising that features interviews with CFS Advisory Committee members Dr. Gailen Marshall and Dr. Susan Levine, and non-voting members Dr. Kenneth Friedman, Leigh Reynolds and Dr. Fred Friedberg. It’s an interesting read, … Continue reading →

Posted in Advocacy | Tagged , , , , , | Comments Off on CFSAC Interviews

Need to Reality

Posted on August 5, 2013 by Jennie Spotila

One of the key moments of the April FDA meeting on drug development for ME/CFS was when Bernard Munos said that ME/CFS patients will have to collect and pool their data to attract the interest of big pharma. Many advocates … Continue reading →

Posted in Advocacy, Research | Tagged , , , , , , , | 7 Comments

Drug and FDA News, July 2013

Posted on July 25, 2013 by Jennie Spotila

The big BIG reminder for the ME/CFS community is that the public comment docket on drug development for ME/CFS will close on August 2, 2013. As of this morning, there are only 201 comments! That’s disappointing, given that FDA said … Continue reading →

Posted in Advocacy | Tagged , , , , | 3 Comments

Drug and FDA News, June 2013

Posted on June 28, 2013 by Jennie Spotila

We’ve had a good discussion in the comments on the advocacy action to request another meeting with FDA. I asked FDA if they would be pursuing Guidance to Industry on ME/CFS drug development, and was told it is already underway. … Continue reading →

Posted in Advocacy | Tagged , , , , | 1 Comment

Precision Is Required

Posted on June 25, 2013 by Jennie Spotila

Post updated June 28, 2013. See end of post for additional information from FDA. Five ME/CFS advocates recently sent a letter to DHHS, FDA and select members of Congress requesting that FDA convene a second meeting with ME/CFS patients “to … Continue reading →

Posted in Advocacy, Commentary | Tagged , , , , , , , | 20 Comments

Requesting an Investigation

Posted on June 18, 2013 by Jennie Spotila

You may recall that at the May 23, 2013 CFS Advisory Committee, voting members Eileen Holderman and Dr. Mary Ann Fletcher stated on the record that they had been intimidated for expressing their views. With assistance from two fellow advocates, … Continue reading →

Posted in Advocacy | Tagged , , , , , , | 9 Comments

No Facts for YOU!

Posted on June 6, 2013 by Jennie Spotila

The NIH funding argument is a broken record: Advocates and researchers say, “We want more funding!” NIH replies, “We need more applications!” And advocates and researchers reply, “Your review panel is made up of dentists!” Back and forth. Back and … Continue reading →

Posted in Advocacy, Research | Tagged , , , , , , , , | 14 Comments